Factors Associated with Head and Neck Cancer Postoperative Radiotherapy Delays: A Systematic Review and Meta-analysis.

OBJECTIVE: Initiating postoperative radiotherapy (PORT) within 6 weeks of surgery for head and neck squamous cell carcinoma (HNSCC) is included in the National Comprehensive Cancer Network Clincal Practice Guidelines and is a Commission on Cancer quality metric. Factors associated with delays in starting PORT have not been systematically described nor synthesized. DATA SOURCES: PubMed, Scopus, and CINAHL. REVIEW METHODS: We included studies describing demographic characteristics, clinical factors, or social determinants of health associated with PORT delay (>6 weeks) in patients with HNSCC treated in the United States after 2003. Meta-analysis of odds ratios (ORs) was performed on nonoverlapping datasets. RESULTS: Of 716 unique abstracts reviewed, 21 studies were included in the systematic review and 15 in the meta-analysis. Study sample size ranged from 19 to 60,776 patients. In the meta-analysis, factors associated with PORT delay included black race (OR, 1.46, 95% confidence interval [CI]: 1.28-1.67), Hispanic ethnicity (OR, 1.37, 95% CI, 1.17-1.60), Medicaid or no health insurance (OR, 2.01, 95% CI, 1.90-2.13), lower income (OR, 1.38, 95% CI, 1.20-1.59), postoperative admission >7 days (OR, 2.92, 95% CI, 2.31-3.67), and 30-day hospital readmission (OR, 1.37, 95% CI, 1.29-1.47). CONCLUSION: Patients at greatest risk for a delay in initiating guideline-adherent PORT include those who are from minoritized communities, of lower socioeconomic status, and experience postoperative challenges. These findings provide the foundational evidence needed to deliver targeted interventions to enhance equity and quality in HNSCC care delivery.

Implementing the Serious Illness Care Program in Safety Net Health Systems: A Qualitative Study.

CONTEXT: Interventions to improve the quality of care for people affected by serious illness commonly fail to reach patients from marginalized and underserved communities, which include those characterized by racialized or indigenous identity, sexual and gender minority status, and rural living. Interventions to improve care through serious illness conversations have demonstrated benefit, but little is known about their implementation in health systems that predominantly serve these patient groups. OBJECTIVES: The study aimed to understand factors influencing implementation of a serious illness communication-focused intervention-the Serious Illness Care Program in health systems who primarily provide care to marginalized and underserved communities. METHODS: Qualitative interviews (16) and focus groups (3) were conducted with 19 interdisciplinary team members from six geographically diverse U.S. healthcare systems. Using a template analysis approach, investigators coded data inductively and deductively to identify themes. RESULTS: Three themes emerged: patient factors, intervention elements, and health system contextual factors. Participants highlighted mission-driven efforts, creativity, interprofessional practice, and trainees as enablers of success. They identified weaknesses in the intervention's communication tool-the Serious Illness Conversation Guide as barriers to implementation of conversations. Resource constraints, socio-economic vulnerability, and mistrust in the health system were seen as additional barriers. CONCLUSIONS: Health systems that provide care to underserved and marginalized communities face unique challenges implementing the Serious Illness Care Program. They also possess assets, some unique to these settings, that support program adoption. Findings suggest that implementation of similar programs in low-resource healthcare settings may help address unmet needs among marginalized populations.

Neighborhood-Level Disadvantage and Delayed Adjuvant Therapy in Head and Neck Cancer.

Importance: For patients with head and neck squamous cell carcinoma (HNSCC), initiation of postoperative radiation therapy (PORT) within 6 weeks of surgery is recommended by the National Comprehensive Cancer Network Guidelines and the Commission on Cancer. Although individual-level measures of socioeconomic status are associated with receipt of timely, guideline-adherent PORT, the role of neighborhood-level disadvantage has not been examined. Objective: To characterize the association of neighborhood-level disadvantage with delays in receiving PORT. Design, Setting, and Participants: This retrospective cohort study included 681 adult patients with HNSCC undergoing curative-intent surgery and PORT from 2018 to 2020 at 4 US academic medical centers. The data were analyzed between June 21, 2023, and March 5, 2024. Main Outcome Measures and Measures: The primary outcome was delay in initiating guideline-adherent PORT (ie, >6 weeks after surgery). Time-to-PORT (TTP) was a secondary outcome. Census block-level Area Deprivation Index (ADI) scores were calculated and reported as national percentiles (0-100); higher scores indicate greater deprivation. The association of ADI scores with PORT delay was assessed using multivariable logistic regression adjusted for demographic, clinical, and institutional characteristics. PORT initiation across ADI score population quartiles was evaluated with cumulative incidence plots and Cox models. Results: Among 681 patients with HNSCC undergoing surgery and PORT (mean [SD] age, 61.5 [11.2] years; 487 [71.5%] men, 194 [29.5%] women) the PORT delay rate was 60.8% (414/681) and median (IQR) TTP was 46 (40-56) days. The median (IQR) ADI score was 62.0 (44.0-83.0). Each 25-point increase in ADI score was associated with a corresponding 32% increase in the adjusted odds ratio (aOR) of PORT delay (aOR, 1.32; 95% CI, 1.07-1.63) on multivariable regression adjusted for institution, age, race and ethnicity, insurance, comorbidity, cancer subsite, stage, postoperative complications, care fragmentation, travel distance, and rurality. Increasing ADI score population quartiles were associated with increasing TTP (hazard ratio of PORT initiation, 0.71; 95% CI, 0.53-0.96; 0.59; 95% CI, 0.44-0.77; and 0.54; 95% CI, 0.41-0.72; for ADI quartiles 2, 3, and 4 vs ADI quartile 1, respectively). Conclusions and Relevance: Increasing neighborhood-level disadvantage was independently associated with a greater likelihood of PORT delay and longer TTP in a dose-dependent manner. These findings indicate a critical need for the development of multilevel strategies to improve the equitable delivery of timely, guideline-adherent PORT.

Factors associated with parental human papillomavirus vaccination intentions among adolescents from socioeconomically advantaged versus deprived households: a nationwide, cross-sectional survey.

Background: In the USA, HPV vaccine coverage is substantially lower among adolescents from high-income households compared to their low-income counterparts. We examined and compared the factors associated with parental HPV vaccination intentions between socioeconomically divergent groups. Methods: Data from unvaccinated and not fully HPV-vaccinated adolescents from the 2017-2021 National Immunization Survey (NIS)-Teen were analyzed. Socioeconomically advantaged vs. deprived groups were identified based on dichotomized income (material capital) and education (social capital). Parental intent to initiate and complete the HPV vaccine series was compared using bivariable analysis and the factors associated with lacking intent were identified. Findings: The 2017-2021 NIS-Teen included a total of 212,643 participants; the final analytical sample consisted of 105,958 adolescents (an estimated 10.3 million adolescents) who were unvaccinated or not fully vaccinated. In the advantaged group, 64.7% of parents of unvaccinated adolescents (equating to 2.4 million US adolescents) had no intention to initiate the HPV vaccine compared to 40.9% of parents in the deprived group (equating to 0.2 million adolescents) (P < 0.0001; S > 13.29). The most frequent reason for lacking intent in the advantaged group was 'safety concerns' (25.5%). In the deprived group, 'lack of knowledge', 'not recommended', and 'not needed' were common reasons (nearly 15% each). Lack of intent to complete the HPV vaccine series was higher in the advantaged group (43.9%; 1.1 million adolescents) compared to the deprived group (25.2%; 0.08 million adolescents) (P < 0.0001; S > 13.29). More than half in the advantaged group (58.4%) and over a third (37.1%) in the deprived group cited 'already up to date' as the main reason for not completing the HPV vaccine series. Interpretation: Lack of intent to initiate and complete the HPV vaccination series, particularly among socioeconomically advantaged parents is a significant barrier to achieving the national goal in the USA. Funding: The US National Institute on Minority Health and Health Disparities, the National Center for Advancing Translational Sciences, MUSC Hollings Cancer Center Seed funding, and the US National Cancer Institutes.

Barriers and facilitators to the implementation of family cancer history collection tools in oncology clinical practices.

INTRODUCTION: This study aimed to identify barriers and facilitators to the implementation of family cancer history (FCH) collection tools in clinical practices and community settings by assessing clinicians' perceptions of implementing a chatbot interface to collect FCH information and provide personalized results to patients and providers. OBJECTIVES: By identifying design and implementation features that facilitate tool adoption and integration into clinical workflows, this study can inform future FCH tool development and adoption in healthcare settings. MATERIALS AND METHODS: Quantitative data were collected using survey to evaluate the implementation outcomes of acceptability, adoption, appropriateness, feasibility, and sustainability of the chatbot tool for collecting FCH. Semistructured interviews were conducted to gather qualitative data on respondents' experiences using the tool and recommendations for enhancements. RESULTS: We completed data collection with 19 providers (n = 9, 47%), clinical staff (n = 5, 26%), administrators (n = 4, 21%), and other staff (n = 1, 5%) affiliated with the NCI Community Oncology Research Program. FCH was systematically collected using a wide range of tools at sites, with information being inserted into the patient's medical record. Participants found the chatbot tool to be highly acceptable, with the tool aligning with existing workflows, and were open to adopting the tool into their practice. DISCUSSION AND CONCLUSIONS: We further the evidence base about the appropriateness of scripted chatbots to support FCH collection. Although the tool had strong support, the varying clinical workflows across clinic sites necessitate that future FCH tool development accommodates customizable implementation strategies. Implementation support is necessary to overcome technical and logistical barriers to enhance the uptake of FCH tools in clinical practices and community settings.

Consumption of Health-Related Videos and Human Papillomavirus Awareness: Cross-Sectional Analyses of a US National Survey and YouTube From the Urban-Rural Context.

BACKGROUND: Nearly 70% of Americans use the internet as their first source of information for health-related questions. Contemporary data on the consumption of web-based videos containing health information among American adults by urbanity or rurality is currently unavailable, and its link with health topic awareness, particularly for human papillomavirus (HPV), is not known. OBJECTIVE: We aim to describe trends and patterns in the consumption of health-related videos on social media from an urban-rural context, examine the association between exposure to health-related videos on social media and awareness of health topics (ie, HPV and HPV vaccine), and understand public interest in HPV-related video content through search terms and engagement analytics. METHODS: We conducted a cross-sectional analysis of the US Health Information National Trends Survey 6, a nationally representative survey that collects data from civilian, noninstitutionalized adults aged 18 years or older residing in the United States. Bivariable analyses were used to estimate the prevalence of consumption of health-related videos on social media among US adults overall and by urbanity or rurality. Multivariable logistic regression models were used to examine the association between the consumption of health-related videos and HPV awareness among urban and rural adults. To provide additional context on the public's interest in HPV-specific video content, we examined search volumes (quantitative) and related query searches (qualitative) for the terms "HPV" and "HPV vaccine" on YouTube. RESULTS: In 2022, 59.6% of US adults (152.3 million) consumed health-related videos on social media, an increase of nearly 100% from 2017 to 2022. Prevalence increased among adults living in both urban (from 31.4% in 2017 to 59.8% in 2022; P<.001) and rural (from 22.4% in 2017 to 58% in 2022; P<.001) regions. Within the urban and rural groups, consumption of health-related videos on social media was most prevalent among adults aged between 18 and 40 years and college graduates or higher-educated adults. Among both urban and rural groups, adults who consumed health-related videos had a significantly higher probability of being aware of HPV and the HPV vaccine compared with those who did not watch health videos on the internet. The term "HPV" was more frequently searched on YouTube compared with "HPV vaccine." Individuals were most commonly searching for videos that covered content about the HPV vaccine, HPV in males, and side effects of the HPV vaccine. CONCLUSIONS: The consumption of health-related videos on social media in the United States increased dramatically between 2017 and 2022. The rise was prominent among both urban and rural adults. Watching a health-related video on social media was associated with a greater probability of being aware of HPV and the HPV vaccine. Additional research on designing and developing social media strategies is needed to increase public awareness of health topics.

Processes for identifying caregivers and screening for caregiver and patient distress in community oncology: results from WF-1803CD.

BACKGROUND: Despite their vital roles, informal caregivers of adult cancer patients are commonly overlooked in cancer care. This study describes processes for identifying cancer caregivers and processes for distress screening and management among caregivers and patients in the understudied community oncology setting. METHODS: Supportive care leaders from the National Cancer Institute Community Oncology Research Program practices completed online survey questions regarding caregiver identification, caregiver and patient distress screening, and distress management strategies. We described practice group characteristics and prevalence of study outcomes. Multivariable logistic regression explored associations between practice group characteristics and caregiver identification in the electronic health record (EHR). RESULTS: Most (64.9%, 72 of 111) supportive care leaders reported routine identification and documentation of informal caregivers; 63.8% record this information in the EHR. Only 16% routinely screen caregivers for distress, though 92.5% screen patients. Distress management strategies for caregivers and patients are widely available, yet only 12.6% are routinely identified and screened and had at least 1 referral strategy for caregivers with distress; 90.6% are routinely screened and had at least 1 referral strategy for patients. Practices with a free-standing outpatient clinic (odds ratio [OR] = 0.29, P = .0106) and academic affiliation (OR = 0.01, P = .04) were less likely to identify and document caregivers in the EHR. However, higher oncologist volume was associated with an increased likelihood of recording caregiver information in the EHR (OR = 1.04, P = .02). CONCLUSIONS: Despite high levels of patient distress screening and management, few practices provide comprehensive caregiver engagement practices. Existing patient engagement protocols may provide a promising platform to build capacity to better address caregiver needs.

Delays Starting Postoperative Radiotherapy Among Head and Neck Cancer Patients: A Systematic Review and Meta-analysis.

OBJECTIVE: Initiating postoperative radiotherapy (PORT) within 6 weeks (42 days) of surgery is the first and only Commission on Cancer (CoC) approved quality metric for head and neck squamous cell carcinoma (HNSCC). No study has systematically reviewed nor synthesized the literature to establish national benchmarks for delays in starting PORT. DATA SOURCES: Following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, we performed a systematic review of PubMed, Scopus, and CINAHL. REVIEW METHODS: Studies that described time-to-PORT or PORT delays in patients with HNSCC treated in the United States after 2003 were included. Meta-analysis of proportions and continuous measures was performed on nonoverlapping datasets to examine the pooled frequency of PORT delays and time-to-PORT. RESULTS: Thirty-six studies were included in the systematic review and 14 in the meta-analysis. Most studies utilized single-institution (n = 17; 47.2%) or cancer registry (n = 16; 44.4%) data. Twenty-five studies (69.4%) defined PORT delay as >6 weeks after surgery (the definition utilized by the CoC and National Comprehensive Cancer Network Guidelines), whereas 4 (11.1%) defined PORT delay as a time interval other than >6 weeks, and 7 (19.4%) characterized time-to-PORT without defining delay. Meta-analysis revealed that 48.6% (95% confidence interval [CI], 41.4-55.9) of patients started PORT > 6 weeks after surgery. Median and mean time-to-PORT were 45.8 (95% CI, 42.4-51.4 days) and 47.4 days (95% CI, 43.4-51.4 days), respectively. CONCLUSION: Delays in initiating guideline-adherent PORT occur in approximately half of patients with HNSCC. These meta-analytic data can be used to set national benchmarks and assess progress in reducing delays.

Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress.

PURPOSE: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT. METHODS: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive five weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the Inventory to Measure and Assess imaGe disturbancE-Head and Neck (IMAGE-HN). Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores. RESULTS: Among 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month resulted in decreases in IMAGE-HN scores from baseline to 3 months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3 months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039). CONCLUSIONS: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03831100 .

A quality improvement study on the feasibility and potential benefits of a yogic breathing program for cancer survivors and caregivers during treatment in a lodging facility.

Background: Complementary and integrative health approaches with a focus on relieving side effects of cancer treatment are popular among cancer patients. Previous studies have investigated the combined effects of yoga postures, breathing, and meditation, but the specific effects of the breathing component are under-reported. Our previous studies indicate that yogic breathing can improve salivary biomarker expression related to stress, immune response, and tumor suppression. We aim to assess the acceptability and feasibility of a yogic breathing program in cancer patients and caregivers during the treatment period. Methods: In this quality improvement study, we designed a 20-minute yogic breathing regimen and introduced them to all-site cancer patients and their caregivers during the cancer treatment period at a lodging facility, Hope Lodge in Charleston, SC. All interested participants were included as there were no eligibility criteria set for the study. The availability of the class was advertised via intercom, displays, and word of mouth. Participants were taught five different breathing exercises, and after completion of the exercises in a single session, a self-reported quality improvement questionnaire was administered assessing sociodemographic/clinical factors, expectations about the session, and ratings of satisfaction with the session. Results: During the nine months of the data collection period, 52 participants provided feedback of which patients and caregivers were almost equal numbers. Participants' perception of intervention acceptance, symptom management, satisfaction with the sessions, and future needs for practice indicate that the yogic breathing sessions help improve some of the key symptoms of cancer experience such as stress. Conclusion: Findings indicate that yogic breathing is acceptable to patients and caregivers and may help alleviate some of the side effects resulting from cancer treatment, and the intervention is feasible at lodging facilities during treatment. Currently, the yogic breathing sessions are conducted on a weekly basis by Hope Lodge volunteers trained by the study team.

Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial.

BACKGROUND: Cigarette smoking remains the leading cause of preventable disease and death in the United States. Primary care offers an ideal setting to reach adults who smoke cigarettes and improve uptake of evidence-based cessation treatment. Although U.S. Preventive Services Task Force Guidelines recommend the 5As model (Ask, Advise, Assess, Assist, Arrange) in primary care, there are many barriers to its implementation. Automated, comprehensive, and proactive tools are needed to overcome barriers. Our team developed and preliminarily evaluated a proactive electronic visit (e-visit) delivered via the Electronic Health Record patient portal to facilitate evidence-based smoking cessation treatment uptake in primary care, with promising initial feasibility and efficacy. This paper describes the rationale, design, and protocol for an ongoing Hybrid Type I effectiveness-implementation trial that will simultaneously assess effectiveness of the e-visit intervention for smoking cessation as well as implementation potential across diverse primary care settings. METHODS: The primary aim of this remote five-year study is to examine the effectiveness of the e-visit intervention vs. treatment as usual (TAU) for smoking cessation via a clinic-randomized clinical trial. Adults who smoke cigarettes are recruited across 18 primary care clinics. Clinics are stratified based on their number of primary care providers and randomized 2:1 to either e-visit or TAU. An initial baseline e-visit gathers information about patient smoking history and motivation to quit, and a clinical decision support algorithm determines the best evidence-based cessation treatment to prescribe. E-visit recommendations are evaluated by a patient's own provider, and a one-month follow-up e-visit assesses cessation progress. Main outcomes include: (1) cessation treatment utilization (medication, psychosocial cessation counseling), (2) reduction in cigarettes per day, and (3) biochemically verified 7-day point prevalence abstinence (PPA) at six-months. We hypothesize that patients randomized to the e-visit condition will have better cessation outcomes (vs. TAU). A secondary aim evaluates e-visit implementation potential at patient, provider, and organizational levels using a mixed-methods approach. Implementation outcomes include acceptability, adoption, fidelity, implementation cost, penetration, and sustainability. DISCUSSION: This asynchronous, proactive e-visit intervention could provide substantial benefits for patients, providers, and primary care practices and has potential to widely improve reach of evidence-based cessation treatment. TRIAL REGISTRATION: NCT05493254.

Development of an Implementation Science Telehealth Toolkit to Promote Research Capacity in Evaluation of Telehealth Programs.

Background: The field of telehealth is rapidly growing and expanding access to quality health care, although there have been varied implementation outcomes in telehealth modalities. Dissemination and implementation (D&I) research can provide a systematic approach to identifying barriers and facilitators to telehealth implementation processes and outcomes. Methods: An interdisciplinary research and clinical team developed an implementation science telehealth toolkit to guide D&I evaluations of new and existing telehealth innovations. Results: The toolkit includes a separate section to correspond to each step in the D&I evaluation process. Each section includes resources to guide evaluation steps, telehealth specific considerations, and case study examples based on three completed telehealth evaluations. Discussion: The field of telehealth is forecasted to continue to expand, with potential to increase health care access to populations in need. This toolkit can help guide health care stakeholders to develop and carry out evaluations to improve understanding of telehealth processes and outcomes to maximize implementation and sustainability of these valuable innovations.

Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress.

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT. Methods: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive 5 weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the IMAGE-HN. Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores. Results: Among 44 HNC survivors with BID, mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month decreased IMAGE-HN scores from baseline to 3-months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3-months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039). Conclusions: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors. Trial Registration: This trial was registered on ClinicalTrials.gov identifier NCT03831100 on February 5, 2019.

Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial.

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors leads to depression, social isolation, stigma, and poor quality of life. BRIGHT ( B uilding a R enewed I ma G e after H ead & neck cancer T reatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID. This trial examines the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. Methods: In this pilot randomized trial, HNC survivors with clinically significant BID were randomized to 5 weekly psychologist-led tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Secondary psychosocial outcomes were assessed using validated patient-reported outcomes at baseline and 1- and 3-months post-intervention. Results: Among 44 HNC survivors with BID, BRIGHT resulted in a greater reduction in depression relative to AC (mean model-based 1-month difference in Δ PROMIS SF v1.0-Depression 8a score, -3.4; 90% CI, -6.4 to -0.4; 3-month difference, -4.3; 90% CI, -7.8 to -0.8). BRIGHT also decreased shame and stigma relative to AC (mean model-based 3-month difference in Δ Shame and Stigma Scale score, -9.7; 90% CI, -15.2 to -4.2) and social isolation (mean model-based 3-month difference in Δ PROMIS SF v2.0 Social Isolation 8a score, -2.9; 90% CI, -5.8 to -0.1). Conclusions: In this planned secondary analysis of a pilot RCT, BRIGHT improved a broad array of psychosocial outcomes among HNC survivors with BID. Implications for Cancer Survivors: These promising preliminary data suggest the need for a large efficacy trial evaluating the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. Trial Registration: ClinicalTrials.gov identifier: NCT03831100.

Efficacy of a brief cognitive behavioral therapy for head and neck cancer survivors with body image distress: secondary outcomes from the BRIGHT pilot randomized clinical trial.

PURPOSE: Body image distress (BID) among head and neck cancer (HNC) survivors leads to depression, social isolation, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID. This trial examines the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. METHODS: In this pilot randomized trial, HNC survivors with clinically significant BID were randomized to 5 weekly psychologist-led tele-CBT sessions (BRIGHT) or dose and delivery-matched survivorship education (attention control [AC]). Secondary psychosocial outcomes were assessed using validated patient-reported outcomes at baseline and 1 and 3-month post-intervention. RESULTS: Among 44 HNC survivors with BID, BRIGHT resulted in a greater reduction in depression relative to AC (mean model-based 1-month difference in Δ PROMIS SF v1.0-Depression 8a score, -3.4; 90% CI, -6.4 to -0.4; 3-month difference, -4.3; 90% CI, -7.8 to -0.8). BRIGHT also decreased shame and stigma relative to AC (mean model-based 3-month difference in Δ Shame and Stigma Scale score, -9.7; 90% CI, -15.2 to -4.2) and social isolation (mean model-based 3-month difference in Δ PROMIS SF v2.0 Social Isolation 8a score, -2.9; 90% CI, -5.8 to -0.1). CONCLUSIONS: In this planned secondary analysis of a pilot RCT, BRIGHT improved a broad array of psychosocial outcomes among HNC survivors with BID. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03831100 . IMPLICATIONS FOR CANCER SURVIVORS: These promising preliminary data suggest the need for a large efficacy trial evaluating the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID.

Anticipating adaptation: tracking the impact of planned and unplanned adaptations during the implementation of a complex population-based genomic screening program.

In 2021, the Medical University of South Carolina (MUSC) launched In Our DNA SC. This large-scale initiative will screen 100,000 individuals in South Carolina for three preventable hereditary conditions that impact approximately two million people in the USA but often go undetected. In anticipation of inevitable changes to the delivery of this complex initiative, we developed an approach to track and assess the impact of evaluate adaptations made during the pilot phase of program implementation. We used a modified version of the Framework for Reporting Adaptations and Modification-Enhanced (FRAME) and Adaptations to code adaptations made during the 3-month pilot phase of In Our DNA SC. Adaptations were documented in real-time using a REDCap database. We used segmented linear regression models to independently test three hypotheses about the impact of adaptations on program reach (rate of enrollment in the program, rate of messages viewed) and implementation (rate of samples collected) 7 days pre- and post-adaptation. Effectiveness was assessed using qualitative observations. Ten adaptations occurred during the pilot phase of program implementation. Most adaptations (60%) were designed to increase the number and type of patient contacted (reach). Adaptations were primarily made based on knowledge and experience (40%) or from quality improvement data (30%). Of the three adaptations designed to increase reach, shortening the recruitment message potential patients received significantly increased the average rate of invitations viewed by 7.3% (p = 0.0106). There was no effect of adaptations on implementation (number of DNA samples collected). Qualitative findings support improvement in effectiveness of the intervention after shortening the consent form and short-term positive impact on uptake of the intervention as measured by team member's participation. Our approach to tracking adaptations of In Our DNA SC allowed our team to quantify the utility of modifications, make decisions about pursuing the adaptation, and understand consequences of the change. Streamlining tools for tracking and responding to adaptations can help monitor the incremental impact of interventions to support continued learning and problem solving for complex interventions being delivered in health systems based on real-time data.

We tracked adaptations to a large-scale population genetic screening program at the Medical University of South Carolina (MUSC) using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME). We found adaptations during program roll-out that impacted implementation outcomes. Our approach to tracking adaptations for the program allowed us to quantify the utility of modifications, make decision about pursuing changes, and understand consequences of adaptations.

Implementation of a women's reproductive behavioral health telemedicine program: a qualitative study of barriers and facilitators in obstetric and pediatric clinics.

BACKGROUND: Perinatal Mood and Anxiety Disorders and Substance Use Disorders are common and result in significant morbidities and mortality. Despite evidence-based treatment availability, multiple barriers exist to care delivery. Because telemedicine offers opportunities to overcome these barriers, the objective of this study was to characterize barriers and facilitators to implementing a mental health and substance use disorder telemedicine program in community obstetric and pediatric clinics. METHODS: Interviews and site surveys were completed with practices engaged in a Women's Reproductive Behavioral Health Telemedicine program (N = 6 sites; 18 participants) at the Medical University of South Carolina and telemedicine providers involved in care delivery (N = 4). Using a structured interview guide based on implementation science principles, we assessed program implementation experiences and perceived barriers and facilitators to implementation. A template analysis approach was used to analyze qualitative data within and across groups. RESULTS: The primary program facilitator was service demand driven by the lack of available maternal mental health and substance use disorder services. Strong commitment to the importance of addressing these health concerns provided a foundation for successful program implementation yet practical challenges such as staffing, space, and technology support were notable barriers. Services were supported by establishing good teamwork within the clinic and with the telemedicine team. CONCLUSION: Capitalizing on clinics' commitment to care for women's needs and a high demand for mental health and substance use disorder services while also addressing resource and technology needs will facilitate telemedicine program success. Study results may have implications for potential marketing, onboarding and monitoring implementation strategies to support clinics engaging in telemedicine programs.

Diabetes Remote Monitoring Program Implementation: A Mixed Methods Analysis of Delivery Strategies, Barriers and Facilitators.

Background: Remote patient monitoring (RPM) is being increasingly utilized as a type of telemedicine modality to improve access to quality health care, although there are documented challenges with this type of innovation. The goals of this study were to characterize clinic delivery strategies for an RPM program and to examine barriers and facilitators to program implementation in a variety of community clinic settings. Methods: Primary data were collected via individual and small group interviews and surveys of clinical staff from South Carolina primary care clinics participating in an RPM program for patients with diabetes mellitus type 2 in 2019. We used a parallel convergent mixed methods study design with six South Carolina primary care outpatient clinics currently participating in a diabetes remote monitoring program. Clinic staff participants completed surveys to define delivery strategies and experiences with the program in a variety of clinical settings. Interviews of clinic staff examined barriers and facilitators to program implementation guided by the Consolidated Framework for Implementation Research (CFIR). Quantitative survey data were summarized via descriptive statistics. Qualitative data from interviews were analyzed in a template analysis approach with primary themes identified and organized by two independent coders and guided by the CFIR. Quantitative and qualitative findings were then synthesized in a final step. Results: RPM program delivery strategies varied across clinic, patient population, and program domains, largely affected by staffing, leadership buy-in, resources, patient needs, and inter-site communication. Barriers and facilitators to implementation were linked to similar factors that influenced delivery strategy. Discussion: RPM programs were implemented in a variety of different clinic settings with program delivery tailored to fit within each clinic's workflow and meet patients' needs. By addressing the barriers identified in this study with focused training and support strategies, delivery processes can improve implementation of RPM programs and thus benefit patient outcomes in rural and community settings.

Patient-Related Factors Do Not Predict Use of Computer-Based Auditory Training by New Adult Cochlear Implant Recipients.

OBJECTIVE: The use of computer-based auditory training (CBAT) after cochlear implantation is associated with improved speech recognition and real-world functional abilities. However, patient-related factors associated with CBAT use remain unknown. This study seeks to identify such factors and recognize those at risk for not implementing CBAT. STUDY DESIGN: Prospective natural experiment. SETTING: Tertiary academic center. PATIENTS: A total of 117 new adult cochlear implant (CI) recipients with bilateral moderate-to-profound hearing loss. INTERVENTIONS/MAIN OUTCOME MEASURES: Patient demographic and lifestyle information, preimplantation aided speech recognition scores, Cochlear Implant Quality of Life (CIQOL) domain and global scores, CIQOL-Expectations scores, and CBAT use in the first 3 months after activation. Patient-related variables included age, sex, race, duration of hearing loss before implantation, hours of CI use per day, hearing-aid use before implantation, living arrangements/marital status, annual household income, employment, technology use, and education. RESULTS: Overall, 33 new CI users (28.2%) used CBAT in the first 3 months after activation. On bivariate analysis of the pre-CI CIQOL scores, CIQOL-Expectations score, aided speech recognition scores, and demographic/lifestyle factors examined, regular use of smartphone, tablet, or computer technology was significantly associated with an increased likelihood of CBAT use (odds ratio, 9.354 [1.198-73.020]), whereas higher CIQOL-Expectations emotional domain scores were associated with a lower likelihood of CBAT use (d = -0.69 [-1.34 to -0.05]). However, using multivariable analysis to control for potential confounding factors revealed no significant associations between CBAT use in the first 3 months after cochlear implantation and any examined factor. CONCLUSIONS: No associations between patient demographic, lifestyle, or pre-CI speech recognition and patient-reported outcome measures and CBAT use were identified. Therefore, discussions with all patients after implantation on the availability of CBAT and its potential benefits are warranted. In addition, given the limited overall use of CBAT and its association with improved CI outcomes, future studies are needed to investigate facilitators and barriers to CBAT use.